Stockholm, Sweden - 8 July 2025 - Modus Therapeutics Holding AB (publ) ("Modus") today announces that patient enrollment in Part 1 of its ongoing Phase IIa study evaluating sevuparin for the treatment of patients with chronic kidney disease (CKD) and anemia has been completed on schedule.
The trial is being conducted at two leading nephrology centers in Italy - Centro Ricerche Cliniche di Verona/Policlinico G.B. Rossi in Verona and the Nephrology & Dialysis Unit at Istituti Clinici Scientifici Maugeri, Pavia - in collaboration with the CRO Latis S.r.l. Part 1 assessed safety and establishes future dose levels after single dosing in patients with CKD stages 3, 4 and 5, as well as in a reference cohort of healthy volunteers. The results will underpin the planned protocol amendment with dose recommendations to the second part of the study which aims to evaluate the therapeutic potential upon repeated dosing of sevuparin (proof of concept) in the same patient type. Modus intends to initiate Part 2 in Q4 2025.
Completion of Part 1 of the Phase IIa study on schedule aligns with the Company's financing strategy for Part 2. The Board on 26 June resolved on a fully secured rights issue of approximately SEK 28.3 million-subject to approval at an extraordinary general meeting on 29 July 2025-to fund the next part of the study.
"Completing enrollment in Part 1 on time is an important milestone and highlights the very successful collaboration with our clinical partners and contract research organizations," said John Öhd, CEO of Modus Therapeutics." We look forward to taking the next step with Part 2 later this year to demonstrate sevuparin's potential as a new treatment for CKD patients with anemia."
For more information on Modus Therapeutics, please contact:
John Öhd, CEO, Modus Therapeutics
Phone: +46 (0) 70 766 80 97
Email: john.ohd@modustx.com
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Website: www.skmg.se
About Modus Therapeutics and sevuparin
Modus is a Swedish biotech company developing its patented polysaccharide, sevuparin, as a treatment option for several major unmet medical needs, including anemia in kidney disease and other chronic inflammatory conditions, severe malaria, sepsis, and other disorders involving severe systemic inflammation. There is a great need for new treatments that can effectively treat these conditions. Modus' ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market ("MODTX"). More information is available at www.modustx.com.
Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested - an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration.
